Bioprocess data management

ABSTRACT

A data management system for a biological process, comprising:
         a. a single-use component,   b. a tag assembly, including a non-volatile memory storage component, that is associated with the single-use component,   c. the memory storage component including a unique identification and a memory, and at least one data element that describes a key performance, calibration or control parameter of the single-use component   d. a memory reader useable to obtain the identification from the memory storage component.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/321,657 filed on Jan. 22, 2009, entitled BIOPROCESS DATA MANAGEMENTby Selker et al., which is a continuation-in-part of Ser. No.12/150,806, filed May 1, 2008, entitled A SYSTEM AND METHOD FOR THEMANAGEMENT OF DATA APPLICABLE TO A BIOLOGICAL PROCESS by Selker et al,which application claims benefit under 35 U.S.C. §119(e) of U.S.Provisional Patent Application No. 60/928,179 filed May 8, 2007,entitled BIOPROCESS DATA MANAGEMENT by Selker et al., all of whichapplications are herein incorporated by reference in their entiretiesand for all purposes.

BACKGROUND OF THE INVENTION

Over the last several decades, biotechnology has become increasinglyfundamental to our society and now has a major impact on the productionof food, medicine, fuel, and materials. This importance and influence onour day to day lives has led to a desire to better monitor and controlthe processes used to implement this technology. In part due to thesereasons, and to end a stagnant period in the technological advancementof drug development, the US FDA has created the PAT (Process AnalyticalTechnology) initiative. This initiative encourages not only largepharmaceutical manufacturers but also smaller modem biotech companies tobring new technological advances into mainstream use to help modernizeand optimize biotech manufacturing. Much of the impetus for the PATinitiative is to bring about advances in monitoring and control so thatdrug manufacturing is safer, more repeatable, more transparent, and lessexpensive and thereby protect the public. For example, in the “ProcessControl Tools” section of the PAT guidance document, it states that:

-   -   “Strategies should accommodate the attributes of the input        materials, the ability and reliability of the process analyzers        to measure critical analytes, and the achievement of process        endpoints to ensure consistent quality of the output materials        and final product.” Design optimization of drug formulation and        manufacturing and processes within the PAT framework can include        the following steps:    -   Identify and measure critical material and bio-process        attributes relating to product quality    -   Development of a process measurement system that allows        real-time or near real-time (e.g. on-line or at-line) monitoring        of critical bio-process/product attributes    -   Design process controls that enable adjustment to ensure that        critical process parameters are controlled    -   Develop mathematical relationships between product quality        attributes and measurements of critical material and process        attributes

Much of this can be summarized to mean that by using advanced monitoringof materials used and process variables (e.g.: pH, dissolved oxygen,dissolved CO₂, glucose, glutamine, lactate, ammonia) mathematical modelsof a bio-process can be created. Through the use of these models, theprocess yield can be predicted and thereby lead to optimized growth runseven if every process parameter is not fully understood. Once monitoringsystems are in-place and models created, advanced control systems can beused to implement the optimization procedures.

In the future, for a typical microbial or cell growth run to conform tothe PAT initiative as outlined above, it is likely that all the rawmaterials and also the data used in the growth process will need berecorded and tracked. For instance, the growth media manufacturer'sformulation specifics, lot data and manufacture date will need to belogged so that issues like contamination, expiration, or other factorsaffecting quality or performance can be tracked. The same will be truefor the actual cell line used, the pH buffer employed, the glucose feed,the sensor manufacturing data, and other inputs. As the trend towardsdisposable bioreactors, disposable sensors, and other disposablematerials mature and become a major part of the manufacturing chainthese items will need to be tracked as well.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1a and 1b are flow charts showing two different process flows forusing a radio frequency identification (RFID) tag as a tracking systemfor single-use bioprocess components:

FIG. 1(a) prior art use flow, versus FIG. 1(b) use flow in accordancewith the present invention. It should be noted that although the presentsystem will be referred to as a “data management” system, itsapplicability encompasses process and process component monitoring(tracking and/or calibration) and also control of a bioprocess.

FIG. 2 is a schematic showing an example of a single-use bioreactortracking system in accordance with the present invention.

FIG. 3 shows the block diagram of a typical gamma radiation resistantferro-electric random access memory (FRAM) nonvolatile memory chip.

FIG. 4 is a schematic showing portions of a data management system inaccordance with the present invention which can suitably utilize a FRAMchip.

FIGS. 5(a) and 5(b) show two examples of single-use bioreactor trackingsystems and their integration into the overall data management andcontrol system: FIG. 5(a) prior art data flow, versus FIG. 5(b) dataflow in accordance with the present invention.

FIG. 6 shows a part of a bio-process control system in accordance withan alternative embodiment of the present invention where the RFID isdirectly attached to the disposable element (e.g., a dissolved oxygenprobe) prior to packaging or sterilization, and the tagged disposableelement is incorporated within a disposable assembly.

FIG. 7 shows a flow diagram in accordance with the present inventionshowing how to implement label security, to ensure that a single-usecomponent is used only once.

FIG. 8 shows overall and also end and partial cut away side views of adisposable sensor assembly suitable for the practice of the presentinvention.

DESCRIPTION OF THE INVENTION

Our invention specifically addresses the need for automated dataacquisition by a control system in bio-process manufacturing. For thetracking of any element (e.g., sensor, other component or bio-processingredient) used in a bio-process, and in order to adhere to theconcepts put forth in the PAT initiative, the bioprocess data management(control) system will need to record information that contains, but isnot limited to:

-   -   1. Calibration and/or performance data    -   2. Serial and lot numbers    -   3. Material certifications    -   4. Aging information

This information can be automatically loaded into a control system or atransmitter that interfaces with the element to be interrogated using avariety of means as discussed in detail below. A transmitter hereconnotes a device that: i) connects to a probe or nonvolatile memorydevice and supplies it with power, ii) can access the probe or readstored information, and iii) has a human/machine interface (HMI) so thatthe data can be displayed and understood. After the data is retrieved,it can be utilized by the control system or by the transmitter tooptimize the bio-process performance or the data can be displayed and/orlogged as part of the data management system. For example, a sensor suchas a dissolved oxygen or pH sensor can have its calibration dataautomatically retrieved in this way. The optimal control algorithm,including growth and feeding strategy, can be automatically implementedif the cell line and growth medium are known, provided only that thisinformation is preprogrammed into the control system. Additionally, anyregulatory agency information required can be recorded with the growthrun data, provided the material certifications and lot numberscontaining this information are automatically read into the system fromthe non-volatile memory device or other information storage device.

The information required to describe, control, and/or automate a modembiotech process will vary in both scope and quantity. Depending on thevolume and sophistication of the data, it can be recorded and read backusing a variety of methods. These methods include:

-   -   1. RFID chip    -   2. Nonvolatile memory/EEPROM    -   3. Internet download    -   4. Other means to semi-automatically read labels or tags such as        holographic stored data markers or fluorescent nano-tags.

The data itself can be embedded in a label, tag, non-volatile memory(e.g.: FRAM), or RFID or surface acoustic wave (SAW) chip.

The prior art (e.g., US2005/0205658 or US2007/0200703), primarilydescribes a data tracking system, wherein a serial number is encoded ina RFID tag that is attached to equipment or components being monitored.The RFID tag is used to retrieve product information such as the lotnumber, date of manufacture, materials certificate numbers, andexpiration date, from a database on a PC over an internet link. The RFIDtag can also have read-write capability, so that the tracking system cancapture data relating to the exposure of the equipment or component toprocesses or environments that can damage it, such as sterilization byautoclaving or chemical cleaning. The RFID tag is resistant to thesecleaning processes and can be re-read many times during the course ofthe use of the component or equipment. The overall purpose of the priorart system is to track the aging of the equipment or component, so thatits failure date can be predicted for scheduled maintenance, and it canautomatically be re-ordered and restocked. The prior art describescollecting data from many samples into a database, in order to estimatethe useful life and time to replacement for the component or equipment.

The prior art pertaining to RFID tags used on single-use bio-processequipment or components (e.g., US2008/0024310A1) that are sterilized bygamma irradiation, specifically states that the product trackinginformation such as serial and lot numbers should be stored on the gammaradiation resistant portion of the tag, but also that additionalinformation, such as the radiation dose, is entered on the tag postirradiation. FIG. 1(a) illustrates the process flow for the RFID tagsdescribed in US2008/0024310A1. Therefore, the use case of the tag in theabove-indicated Published Patent Application requires that at least aportion of the RFID tag memory must be gamma radiation resistant, arequirement that is satisfied by the FRAM technology utilized bycompanies such as Fujitsu and others. In contrast, the present inventiondescribes labels, including but not limited to RFID tags, where theentirety of the information pertaining to the component is entered priorto the final sterilization step, rather than as a sequence during themanufacturing or assembly process for the component (e.g., filling a bagwith media, or inserting a sensor into a bioreactor liner bag). Theprocess flow for the present invention is shown in FIG. 1(b).

Unlike the present invention, the prior art does not describe or suggesta label or tag that carries process-specific or sensor calibration data,and also is usable to control a bioprocess and/or measure parameters ofthe bioprocess in real-time. The prior art also assumes that the data isboth written to and entered from an external database rather than atransmitter and/or controller directly associated with both thebio-process and the component being used. Finally, the prior art assumesthat the RFID tag is writeable (can be written to) and that the userwill input more than one process event on the tag. In the presentinvention, the label (tag) is exclusively associated with a single-usecomponent, and is therefore read only once, at the start of thebio-process, because it is discarded after the bio-process is complete.Other prior art pertaining to water quality monitoring tools (e.g., U.S.Pat. No. 7,007,541) is primarily aimed at re-usable sensors whosecalibration constants change with aging or interchangeable sensors wherethe re-usable sensor heads are each unique enough that their parametersneed to be accounted for systematically.

When using a semi-automatically-readable (take to reader) label (tag)such as a set of magnetic stripes (or equivalent marking system) or amemory device based on SAW (surface acoustic wave) chips, the reading ofthe data will advantageously be semiautomated. In the present contextsemi-automated means that the user will not need to manually enter thedata describing the component, and will only need to bring a reader intosufficiently close proximity and with a specific orientation in order toaccomplish the data transfer to the reader. An example in accordancewith the present invention is shown in FIG. 2. In FIG. 2, 2.1 is adisposable element on which an encoded label 2.2 resides, 2.3 is are-useable element, and 2.4 is the transmitter to which 2.3 isconnected, 2.5 is an automation system that consists of both controlsoftware and hardware. A label reader 2.6 is shown connected to theautomation system. Since the system is in communication with thetransmitter 2.4, the label 2.2 information can be used by thetransmitter. The disposable element 2.1 can, for example, be adisposable sensor, a disposable (single use) bioreactor vessel, acontainer of a particular microbe or cells from a cell bank, growthmedium, pH buffer, or any other input or process variable used in agrowth run or similar biotechnology process.

Another level of automation is the use of a non-volatile memory storagecomponent such as FRAM (ferro-electric based random access memory chip)or an EEPROM (Electrically Erasable Programmable Read-Only Memory) chip(equivalent functionality to a label) to store data and provide aninterlock for the system. A system using nonvolatile memory chips suchas a FRAM or an EEPROM can be employed for any component that is pluggedinto (i.e., is physically connected to) the system. For instance, ifusing a disposable bioreactor vessel and/or a set of disposable sensors,the disposable elements can be plugged into the data management(control) system of the present invention. For example, if thebioreactor under study is a disposable bioreactor or bioreactor usingdisposable elements, the recorded information regarding the date ofmanufacture, the materials used and their certifications, (e.g.: growthmedia, sensor calibration data etc.) can all be automatically loadedinto the control system memory from the nonvolatile memory after it isplugged into the system. A FRAM based nonvolatile memory is inexpensiveand therefore can be readily disposed of with the disposable componentafter a single use.

The gamma radiation resistant, nonvolatile memory allows for thetransfer of calibration or other information from the factory to theapparatus without concern for the possibility of operator error. This isa significant advance over the current state of the art which calls foran operator to enter this type of information via a keypad or byscrolling through alpha numeric characters one at a time. Any particular(or all) information can be encrypted in order to verify itsauthenticity and to protect it from alteration or tampering. This alsoallows the manufacturer to provide a unique identification code for eachdevice/component for traceability purposes. This unique identificationcode thus allows the data management (control) system to control thenumber of times, duration, or conditions under which the component isused, and can therefore be used to prevent reuse, misuse and fraud. Suchmisuse can, for example, include trying to use pre-sterilizeddisposables more than once. FIG. 3 shows a block diagram of aFRAM-based, non-volatile memory chip. EEPROM's can also be obtained thatare gamma radiation resistant, but to date these devices are moreexpensive and therefore somewhat less appealing in certain cases.

FIG. 4 depicts a typical application using a control system inaccordance with the present invention. In FIG. 4, 4.1 is the disposableelement, 4.2 is the FRAM or equivalent non-volatile storage element, 4.3is a re-usable element or reader into which 4.1 is connected, 4.4 is atransmitter which can optionally interact with either the reusableelement 4.3 or with the FRAM. When the disposable element 4.1 isconnected to the reusable element 4.3, the data in the FRAM is read andprocessed as discussed above. The automation system, 4.5, is connectedto the transmitter, and can act as the master controller or therepository for data read into the transmitter. Element 4.1 can be adisposable sensor, a disposable element for a bioreactor such as a valveor bag or a similar single-use item. As many of the disposable orsingle-use components in a bioprocess are relatively small, the size ofthe FRAM can be important. Many non-volatile memory storage components(chips) are physically large in order to help enhance their gammaradiation resistance which can pose a problem for locating the memorydevice on the disposable component. In general, chips that are similarin shape to a standard SOIC (small outline integrated circuit) packageor a flat-pack with leads coming from all 4 sides of the chip willadvantageously be utilized. The optimal chip will therefore preferablyhave a surface area no larger than about 1 cm² and be no thicker thanabout 1 mm and most preferably be approximately 6 mm×6 mm and 0.5 mmthick.

A similar result can be accomplished through the use of an RFID-basedtagging system. Similar to the nonvolatile memory and the label systemsdescribed above, this embodiment of the present invention enables one toperform the following functions:

1. Transfer data and information from the manufacturer's calibrationdatabase or data storage to the control system without operator error.

2. Eliminate time consuming manual data entry via a keypad or bysequentially scrolling through alpha numeric characters one at a time.

3. Encrypt data and information to guarantee its authenticity.

4. Transfer information without out any physical contact or particularorientation of the RFID tag.

5. Provide a log of each unique identification tag for traceability, aswell as to minimize possibility of misuse or fraud.

A benefit resulting from using an RFID tag system is that theidentification system does not need to be physically attached to thedisposable element. This method enables one to tag the disposableelement or disposable sensor instrument (or the package that containsit), such that it can be tracked from manufacturing to final use. TheRFID tag preferably includes a unique identification number. The tagalso carries the aforementioned information in its nonvolatile memory.The information is advantageously encrypted and check-summed in order toprevent tampering and/or invalid calibration. In one example (FIG. 1(b),the RFID tag is attached to the disposable element and product specificinformation is entered on the tag prior to sterilization. The RFID tagis then sterilized together with the disposable element (component). Forexample, if this is a sensor, it will be the calibration data and otherapplicable manufacturing information; for a disposable bioreactor, itcan be the films used; for growth medium, it can be the lot and serialnumber for process tracking. This RFID tag system can be used with anydisposable bioprocess components that will benefit from havinginformation managed. The size of the RFID tag can be important as theefficacy is related to the size. The larger the RFID tag's area,typically the larger the antenna of the tag and hence the greaterdistance it can be from a reader and still be read. However, smallertags with the antenna constructed of multiple loops are also effectiveand are therefore preferred. In general, the tag needs to be largeenough to satisfy the distance requirements for its use, yet smallenough that it can still be packaged with the single-use component whichneeds to be tracked, calibrated, or otherwise have its data managed. TheRFID tag will therefore preferably have a substantially planarconfiguration and a surface area no greater than about 150 cm².

In the prior art techniques, the data flow to and from the label on thedisposable element bypasses the automation system associated with thebioprocess in which the disposable element is used. FIG. 5a illustratesthe data flow as described in published applications US2005/0205658,US2007/0200703, and US2008/0024310A1. In these cases data from RFID tag5.1 is read or written by reader 5.2 to computer 5.3 that links into anexternal database 5.4. Database 5.4 is either stored on computer 5.3 oris external, with Ethernet access from computer 5.3. Such data flow isappropriate for a system that is associated with manufacturing quality,materials requirements planning, or enterprise resource planningsystems. Such a prior art system can generate a database that providesinformation to estimate useful service life and time to failure forcomponents, as well as an ability to re-order inventory. However, such adatabase is only useful for the control of a bio-process system in theevent of a process failure, when materials certificates and serialnumbers must be accessed for a root cause analysis of the failure.

In the present invention, as in the embodiment shown in FIG. 5b , thedata flow from the disposable element label 5.5 occurs through reader5.6 into either transmitter 5.7, whose output is connected to controller5.8, or directly into controller 5.8. The process data containing thelabel information is then saved in 5.9 (the system historian orhistorical database) as part of the batch record, or as a processparameter. The data from label 5.5 is used either by transmitter 5.7 orcontroller 5.8 during the bio-process, in order to effect control of thebio-process. For example, calibration constants can be used by thetransmitter to calculate sensor output values that are sent to thebio-process automation system, which then actuates pumps or mass flowcontrol valves; or the amino acid concentration in the media of apre-filled bioreactor bag is used by the control system to predictfeeding and cell growth rates after inoculation. In both of theseexamples, the data from the label/non-volatile memory is actively usedto control the bio-process, and generates additional, associated processdata that can be used to characterize the effectiveness of thedisposable element in the process for future runs. This use ofdisposable labels is equally applicable to upstream (cellculture/fermentation), downstream (purification), or fill-finishbio-processes.

Furthermore, the control system 5.8 can be linked to a materialsrequirements planning system within the fabrication facility 5.10, suchas SAP or Oracle, update the inventory levels automatically after thecompletion of the process using the disposable element, and inputprocess feedback into the plant management system. Unlike the prior art,which requires human intervention to an external database, thisinventory management can be performed completely automatically using thedata management system of the present invention.

In the present invention, the ID number that is stored on the label orother non-volatile memory may correspond to product specificationinformation for the component, such as materials certifications, lotnumbers, manufacturing date, and/or sterilization records. Thisinformation can be stored in a remote database, for example, a sectionof the supplier's database that is only accessible by the end user orOEM customer. In contrast to the prior art, where the informationaldatabase must be accessed manually by the user, in the presentinvention, the database URL address and an optional encrypted key-codefor remote database access are also stored on the label or tag and areread out by the transmitter or automation system. If either transmitteror automation system is connected to the internet via the Ethernet, itcan automatically access the URL, enter the optional key-code, andautomatically gain access to the database information, in order todownload it and store it in the process batch record. Alternatively, ifthe bio-process automation system and/or transmitter are programmed tohave their own user ID and password to the database and the URL has beenalready entered into their memory, only the component's ID numberrequired from each label or tag, and database access remains automatic.

Most systems in accordance with the present invention will utilize adisposable element such as a sensor element or a disposable element thatcomprises a sensor element, a reusable component that holds theelectronics measuring the sensor response and which interfaces to thetransmitter, and also an RFID tag having both a unique identifier and anonvolatile memory element. A process for utilizing the system of thepresent invention would proceed according to the following steps:

-   -   1. The disposable (e.g.: sensor) element is first calibrated        using a known method.    -   2. After the calibration and performance data for the disposable        element is generated, it needs to be associated with the single        use component for which the data was generated in the        bio-process.    -   3. The disposable element is sealed in a bag with a visible        identifying number or tag, such as a paper label.    -   4. The bag containing the disposable element is gamma irradiated        and a RFID tag is applied to the outside of the bag.    -   5. A computer program encodes the calibration information on the        RFID tag, along with any additional information pertaining to        the disposable element, such as material certificate numbers,        batch numbers, etc.    -   6. This information is stored in the RFID tag's nonvolatile        memory elements.    -   7. The RFID tag's unique identifier is recorded visibly on its        exterior for ease of identification.

Once the disposable element is ready to be used, it is taken to thereusable element where a scanner (reader) reads the data from RFID tag,both the unique identifier and also the nonvolatile memory elements. Thereusable element will have an associated transmitter or processor thatdecodes and applies the information it has read from the RFID tag. Thedisposable element can now be used with minimal intervention by the enduser. If this is a sensor, it is now ready to take measurements; if itis disposable bioreactor system then all of the relevant data on thebag, the growth media, configuration, batch ID, etc., is now enteredinto the control system.

Note that in the embodiment illustrated in FIG. 6, 6.1 is the disposableelement, 6.2 is the reusable element, and 6.3 are the RFID readers whichcan be located either in the transmitter 6.4 or the automation system6.5. The RFID tag 6.6 is directly attached to the disposable element6.1, and the calibration or other data is written onto the non-volatilememory of the RFID tag using a computer. The disposable element may theneither be integrated into a larger assembly 6.7, such as a bioreactorbag for a disposable sensor or component and packaged in a bag 6.8, orbe separately and directly packaged in a bag 6.8. The assembly 6.7,including any attached RFID tags, is then sterilized, eitherindividually, or as a group on a pallet. When the assembly 6.7 is usedin a bio-process, used each tag is removed from its associated componentand scanned into the system.

The re-usable element, or the system to which the re-usable element isconnected, will also preferably have its own nonvolatile storage. Thismemory can be used to log the usage of the disposable elements. Forexample, this usage log can be utilized to verify that the disposableelement has never been used before. If the unique identification numberhas been used before or does not conform to a validation algorithm, theidentification is invalidated and a warning to this effect is giventhrough the interfaces. The architects of the system can decide how muchor how little to minimize the user's activity. FIG. 7 shows an exampleof a flow diagram associated with RFID security, so that a single-usecomponent cannot be re-used, and thereby not cross-contaminate asubsequent process.

Referring now to FIG. 8, there is illustrated overall (8.1) and also endand partial cut away side views of a disposable sensor assembly suitablefor the practice of the present invention. 8.2 denotes electrodes whichenable the non-volatile memory (such as a FRAM) 8.3 to interface withthe transmitter such as that designated as 5.7 in FIG. 5.

The invention claimed is:
 1. A calibration system for use with sensorsand control systems for a biological process, the calibration systemcomprising: (a) a single-use component comprising a sensor, thesingle-use component being configured to measure a process controlparameter used to control the biological process; (b) a non-volatilememory storage component affixed to the single-use component and whichis programmed prior to gamma irradiation of the memory storage componentand the single use component to which it is affixed, wherein the memorystorage component is resistant to the gamma radiation; and (c) thememory storage component storing at least one already entered, prior togamma irradiation, data element that provides a calibration parameterfor calculating sensor output values from the single-use component toenable the single use component to measure the process control parameterin real time, wherein the non-volatile memory storage component isconfigured to be non-writable by a user after the gamma irradiation. 2.The calibration system of claim 1, wherein the single-use component isan assembly of a plurality of single-use components and at least onetag.
 3. The calibration system of claim 1, further comprising a memorycard reader, wherein the memory reader is a transmitter.
 4. Thecalibration system of claim 1, wherein the process control parameter ispH, dissolved oxygen, dissolved CO₂, temperature, pressure, level, foam,cell density, cell viability, an anti-foam additive, an amino acid, or abio-process end product selected from the group consisting of a protein,an antibody, a plasmid, and a metabolite selected from the groupconsisting of glucose, lactate, glutamine, glutamate and ammonia.
 5. Thecalibration system of claim 1, wherein the non-volatile memory storagecomponent utilizes a ferro-electric RAM.
 6. The calibration system ofclaim 1, wherein the memory storage component comprises a RFID tagcomprising a material resistant to gamma radiation.
 7. The calibrationsystem of claim 6, wherein the RFID tag has a substantially planarconfiguration and a surface area no greater than about 150 cm².
 8. Thecalibration system of claim 6, wherein the memory storage componentutilizes FRAM.
 9. The calibration system of claim 1, wherein the memorystorage component utilizes an EEPROM.
 10. The calibration system ofclaim 1, wherein the data element comprises at least one calibrationconstant for the sensor.
 11. The calibration system of claim 1, whereinthe data element describes at least one additive present in a biologicalprocess media.
 12. The calibration system of claim 1, wherein thenon-volatile memory storage component has a surface area no larger than1 cm² and is no thicker than 1 mm.
 13. The calibration system of claim1, wherein the single use component and the affixed non-volatile memorystorage component are integrated into a single-use bioreactor assemblyprior to gamma irradiation sterilization of the single-use bioreactorassembly.
 14. The calibration system of claim 13, wherein the single-usebioreactor assembly comprises a single-use bioreactor bag.
 15. Thecalibration system of claim 1, wherein the single-use component and thenon-volatile memory storage component are configured to be physicallyconnected to a memory reading system when utilizing the calibrationparameter.
 16. The calibration system of claim 15, wherein thesingle-use component comprises four electrodes.
 17. The calibrationsystem of claim 1, wherein the memory storage component storesadditional information selected from the group consisting of amanufacturing date, a batch number, a lot number, materialspecifications, material lot number, certifications for sterility,certificates of compliance, size specification, functionalspecifications, description of device, expiration date, process data,lifetime data, composition data, and a unique identification code. 18.The calibration system of claim 17, wherein the additional informationcan be used by the biological process control system to ensure that thesingle use component is used only once.
 19. The calibration system ofclaim 17, wherein both the calibration parameter and the additionalinformation are programmed to the memory storage component prior to thegamma irradiation of the memory storage component and the single usecomponent.
 20. The calibration system of claim 1, wherein no furtherinformation is programmed to the memory storage component after thegamma irradiation of the memory storage component and the single usecomponent.
 21. A method of calibration in a biological process, themethod comprising: (i) permanently affixing a non-volatile memorystorage component to a single use component configured to measure aprocess control parameter for the biological process, wherein thenon-volatile memory storage component is resistant to the gammaradiation; (ii) entering a data element in the non-volatile memorystorage component, wherein the data element comprises a calibrationparameter for calculating sensor output values from the single usecomponent to thereby enable the single use component to measure theprocess control parameter; (iii) after (ii), gamma radiation sterilizingthe single use component and the affixed non-volatile memory storagecomponent; (iv) after (iii), reading and using the calibration parameterentered on the non-volatile memory storage component to measure theprocess control parameter; and (v) transmitting a measured processcontrol parameter to a control system for controlling the biologicalprocess, wherein the non-volatile memory storage component is configuredto be non-writable by a user after the gamma irradiation.
 22. The methodof claim 21, further comprising, after (iii), reading and validating theat least one data element present on the non-volatile memory storagecomponent.
 23. The method of claim 21, wherein the single-use componentand the non-volatile memory storage component are configured to bephysically connected to a memory reading system when utilizing thecalibration parameter.
 24. The method of claim 21, wherein during (iii),the at least one data element and the calibration parameter aretransmitted from the non-volatile memory storage component throughelectrodes that interface with a memory reading system.
 25. The methodof claim 21, further comprising: (vi) discarding the non-volatile memorystorage component and the affixed single use component after completionof the biological process.
 26. The method of claim 21, furthercomprising entering an encrypted URL on the non-volatile memory storagecomponent prior to (iii).
 27. The method of claim 21, further comprisingintegrating the single use component and the affixed non-volatile memorystorage component into a single-use bioreactor assembly prior to gammaradiation sterilization of the single-use bioreactor assembly.
 28. Themethod of claim 21, wherein entry of the data element on thenon-volatile memory storage component is effected when the non-volatilememory storage component is fabricated.
 29. The method of claim 21,wherein the process control parameter is pH, dissolved oxygen, dissolvedCO₂, temperature, pressure, level, foam, cell density, cell viability,an anti-foamadditive, an amino acid, or a bio-process end productselected from the group consisting of a protein, an antibody, a plasmid,and a metabolite selected from the group consisting of glucose, lactate,glutamine, glutamate and ammonia.
 30. The method of claim 21, furthercomprising storing additional information in the memory storagecomponent, wherein the additional information is selected from the groupconsisting of a manufacturing date, a batch number, a lot number,material specifications, material lot number, a certification forsterility, a certificate of compliance, a size specification, afunctional specification, a description of a device, an expiration date,process data, lifetime data, composition data, a unique identificationcode, and combinations thereof.
 31. The method of claim 30, wherein boththe calibration parameter and the additional information are programmedto the memory storage component prior to the gamma irradiation of thememory storage component and the single use component.